Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs
This study has been completed.
Sponsor:
Pfizer
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002328
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
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Purpose
To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.
Condition | Intervention |
---|---|
Cryptosporidiosis HIV Infections |
Drug: Azithromycin |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | Oral/Intravenous Azithromycin in the Treatment of Cryptosporidiosis in Patients Whose Disease Has Not Been Controlled by Conventional Therapy |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients must have:
- Cryptosporidiosis infection.
- Life expectancy of at least 1 week.
- Failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic or other therapies for cryptosporidiosis.
- Consent of parent or guardian for patients under the legal age of consent. Patients with documented favorable response to azithromycin under Pfizer protocol 066-143 may receive maintenance therapy under this protocol.
Patients with persistent diarrhea requiring intravenous (IV) fluid therapy to maintain hydration may receive IV azithromycin after approval by the clinical monitor. Patients whose disease worsens despite a minimum of 2 weeks of oral therapy or patients whose disease shows no improvement after 4 weeks of oral therapy will also be considered for a trial period of intravenous azithromycin.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity or significant intolerance to macrolide antibiotics.
- Eligibility and current treatment at a medical center performing study 066-143, another study of azithromycin for treatment of cryptosporidiosis in AIDS patients.
Required:
- Must have failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic therapies for cryptosporidiosis.
Contacts and Locations
More Information
No publications provided
Keywords provided by NIH AIDS Clinical Trials Information Service:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 07, 2013
No publications provided
ClinicalTrials.gov Identifier: | NCT00002328 History of Changes |
Other Study ID Numbers: | 058J, 066-167S |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Antidiarrheals Cryptosporidiosis Diarrhea Acquired Immunodeficiency Syndrome Azithromycin |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Cryptosporidiosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Intestinal Diseases, Parasitic |
Parasitic Diseases Protozoan Infections, Animal Parasitic Diseases, Animal Coccidiosis Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 07, 2013